Regulatory Affairs DirectorPosted: October 27, 2009
Position Summary: The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lombs pharmaceutical products throughout their lifecycle, which includes Brand, Generics, OTC/Nutritionals, and dietary supplements. Responsible for the overarching global pharmaceutical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Pharmaceutical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and CMC). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. Specific Job Duties: * Serve as a leadership team member for Bausch & Lombs Pharmaceutical Regulatory Affairs function * Oversee the development of global product regulatory strategies for all Bausch & Lomb pharmaceutical products * Oversee the regulatory functions in relation to drug development and product approvals, consistent with Bausch & Lomb agreed upon timelines * Manage interactions with Regulatory Authorities for pharmaceutical products * Build relationships with Bausch & Lomb Global Regulatory Affairs function * Provide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections * Provide regulatory guidance/input to internal product review boards * Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance * Play a significant role in the performance management process and career development programs for supervised regulatory personnel Technical Competencies: * Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including * Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations * Knowledge of domestic and international laws, regulations, and guidance * Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization * Ability to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams * Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval * Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data Professional Competencies: * Strong capability to lead and support a collaborative team environment * Demonstrated ability in analytical reasoning and critical thinking skills * Ability to manage in a highly matrix organization * Demonstrated ability to lead a multidisciplinary team * Strong business acumen and ability to see the business drivers outside of Regulatory Affairs * Excellent communication skills; both oral and written * Strong interpersonal skills with the ability to influence others in a positive and effective manner * Demonstrated ability to contribute to a continuous learning and process improvement environment * Capacity to react quickly and decisively in unexpected situations * Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies * Focused ability to influence operational excellence and performance metrics * Risk adverse where needed with the ability to identify potential solutions to complex problems Please refer to job code 753823 when responding to this ad.
|
